Device recall
Z-0748-2014: Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation…
FDA device recall · Class II · GE Healthcare It
Key facts
| Recall number (Z-number) | Z-0748-2014 |
|---|---|
| Recall event | 65366 |
| Product | Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three… |
| Product code | LLZ |
| Recalling firm | GE Healthcare It |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2016 |
| 510(k) numbers | K040468 |
| FEI number | 3004526608 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database